Intralesional Cryosurgery Alone Versus Combined With 5-FU and Triamcinolone for Keloids
Efficacy and Safety of Intralesional Cryosurgery Alone and in Combination With Intralesional 5-fluorouracil/Triamcinolone Acetonide Injection for Treatment of Keloids: a Comparative Clinical Study
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
evaluate the efficacy and safety of intralesional cryosurgery alone compared with intralesional cryosurgery combined with intralesional 5-fluorouracil and triamcinolone acetonide in the treatment of keloids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
Study Completion
Last participant's last visit for all outcomes
August 1, 2027
April 13, 2026
April 1, 2026
1 year
April 5, 2026
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in keloid size
Keloid severity will be assessed using the Vancouver Scar Scale (VSS), which evaluates vascularity, pigmentation, pliability, and height. Scores range from 0 to 13, with higher scores indicating more severe scarring. Assessment will be performed by blinded observers.
12 weeks
Secondary Outcomes (1)
Patient Scar Assessment (PSAS)
up to 12 weeks
Other Outcomes (1)
Change in dermoscopic vascular patterns and pigmentation
up to 12 weeks
Study Arms (2)
Cryotherapy + Saline Injection (Placebo)
EXPERIMENTALPatients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Cryotherapy + TAC/5-FU Injection
EXPERIMENTALPatients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
Interventions
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
Eligibility Criteria
You may qualify if:
- Adult patients (≥18 years) with clinically diagnosed keloids .
- Keloids of size 1-10 cm in greatest dimension .
- Keloids of at least one year duration
You may not qualify if:
- Females who are pregnant, planning pregnancy, or lactating .
- Hypertrophic scars .
- Chronic kidney or liver disease (relevant for 5-FU safety) .
- Patients with active inflammation, infection, or ulcer at or around the keloid or Lesions suspicious for malignancy .
- Patients who received any treatment for the same keloid in the past 12 months .
- Immunosuppressed patients or those with chronic inflammatory diseases .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Abdel-Meguid AM, Weshahy AH, Sayed DS, Refaiy AE, Awad SM. Intralesional vs. contact cryosurgery in treatment of keloids: a clinical and immunohistochemical study. Int J Dermatol. 2015 Apr;54(4):468-75. doi: 10.1111/ijd.12667. Epub 2014 Nov 28.
PMID: 25442108RESULTWeshahy AH, Abdel Hay R. Intralesional cryosurgery and intralesional steroid injection: a good combination therapy for treatment of keloids and hypertrophic scars. Dermatol Ther. 2012 May-Jun;25(3):273-6. doi: 10.1111/j.1529-8019.2012.01456.x.
PMID: 22913446RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- "To ensure blinding, patients in the control group will receive intralesional saline injections as a placebo. Clinical and dermoscopic evaluations will be performed by two independent observers blinded to the treatment groups."
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Student / Dermatology Department
Study Record Dates
First Submitted
April 5, 2026
First Posted
April 13, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04